请仔细阅读罗可曼（重组人红细胞生成素-β注射液）的作用说明，并在药师指导下购买和使用。

【药品名称】罗可曼（重组人红细胞生成素-β注射液）

【通用名】重组人红细胞生成素-β注射液

【成分】重组人类红细胞生成素-β，倍他依泊汀，生血素

【适应症】罗可曼适用于因慢性肾衰竭引致贫血的透析病人。

【包装规格】2000IU ×6

【用法用量】本品易于使用，只有在溶液澄清或呈轻微乳状，无色且几乎无可见颗粒时方可用于注射。预充式注射器中的药品是无菌的，但未做防腐处理。在任何情况下，每支注射器都不可以多次注射。皮下或静脉注射。静脉注射应在约2分钟内完成。例如，在血透过程末段经动静脉瘘管注入。对非血透病人，皮下注射要避免误穿入外周静脉。治疗目标为增加血细胞比容在30-35%之间，每周平均增幅最少0.5%，最高水平不能超过35%，如存在高血压或心血管疾病，脑血管或末梢血管病症等情况，应按个体状况来确定每周升幅及目标水平。对部分病人来说，理想水平可能低于30%。本品的治疗方案分两步骤：治疗期：皮下注射开始时治疗剂量为每周3次，每次20IU/公斤体重。如4周后发现血细胞比容增加不理想(每周增加少于0.5vol%)，每次剂量可增加20IU/公斤体重，每周3次。同时也可将每周剂量分成每日剂量静脉注射 开始时治疗剂量为每周3次，每次40IU/公斤体重。如发现血细胞比容增加不理想(每周增加少于0.5vol%)，可于4周后将剂量增加至每周3次，每次80IU/公斤体重。其后每月每次可再增多20IU/公斤体重，每周3次。 　　以上两种给药途径，最高剂量不可超过每周720IU/公斤体重。维持期：要达到维持血细胞比容在30vol%-35vol %之间，首先把剂量减至治疗期剂量的一半，然后每周或每两周调整剂量(维持剂量)。对儿童所做的临床观察结果显示，平均来说，病人越年轻，本品维持剂量越高，然而，由于个别病人反应不同，难于估计，所以应按照建议剂量应用本药。本品一般用于长期治疗，但如有需要，可随时终止治疗。

【不良反应】心血管系统本品治疗期间出现最多的不良反应是血压增高或使已存在的高血压恶化，尤其是在PCV快速增加的病人中。这种血压增高可用药物治疗。假如血压增高不能被药物控制，推荐治疗暂停。特别在治疗开始时，应定时监测血压变化，包括透析期间。高血压危象伴随脑病样症状(如头痛、眩晕、感觉紊乱象语言混乱或阵挛性发作)可能会发生，甚至在正常血压或低血压病人中也会发生。这类病人应予以密切监测及强有力的药物干预。特别要注意出现急性针刺性偏头痛者。血液 本品治疗期间，尤其静脉注射后，可能会出现一个中等程度的剂量依赖性的血小板计数上升。在维持治疗中，这种现象会回退。血小板增多继续发展非常少见，推荐在治疗前8周经常监测血小板计数。血透过程中需要肝素剂量增高是PCV增高的结果。由于肝素化不充分，透析系统可能发生堵塞。旁路血栓形成可能会发生，尤其是病人有低血压倾向或动静瘘等并发症(如狭窄、动脉病)。在这些病人中，推荐给药阿司匹林早期修正旁路和预防栓塞。在多数病例，血清铁蛋白的降低与PCV增高同时发生。因此对于所有血清铁水平低于100μg/l或转铁饱和度低于20%的病人均推荐给予口服铁剂200-300mg/天。个别病例发现，有短暂高钾血症和高磷酸盐血症，这些参数须经常监测。其它 皮肤反应诸如皮炎、瘙痒、暑麻疹或注射部位反应亦会发生(但很少)。在个别病例，有报导过敏反应发生。然而，在对照性临床研究中，并没有发现高敏反应的机率增高。

【禁忌】本品禁用于高血压失控的病人及已知对其中成分高度敏感者。警告：正常人如错误使用(例如用做刺激药物)，可能会导致细胞比容过多，因而引起各种致命的心血管系统并发病。

【注意事项】既然有一些个别病例曾发生过敏性反应，推荐第一次注射应在医生监督下使用。在顽固性贫血伴有血中过多未成熟细胞、癫痫、血小板溶解和慢性肝衰时，本品治疗必须小心。叶酸及维生素B12缺乏会降低本品的效果，故应排除。治疗肾衰所致的严重的铝负荷可能会使本品的效果降低。对未经透析的肾硬化病人，本品的治疗需由个人情况而限定，因它加速肾衰进展的可能性不能排除。本品治疗过程中，应定期监测血清钾和磷水平。有报导某些使用本品的尿毒症病人有血钾升高，虽然尚未建立二者之间的因果关系。假如发现血钾升高，应考虑停止治疗直至血钾恢复正常。重要配合禁忌：为避免引致不相配合或影响活性，切勿与其他药物或溶剂混合使用。

【孕妇用药】动物研究表明，在治疗状态下无致畸胎性。但在人类怀孕及哺乳期没有足够经验。在怀孕及哺乳期的妇女，本品只能用于潜在效益大于风险时

【药物相互作用】到目前为止，临床结果还未显示本品与其他药物有相互作用。

【生产厂家】罗氏制药有限公司

NeoRecormon

Active Substance: epoetin beta 
Common Name: epoetin beta 
ATC Code: B03XA01
Marketing Authorisation Holder: Roche Registration Limited
Active Substance: epoetin beta 
Status: Authorised
Authorisation Date: 1997-07-16
Therapeutic Area: Anemia Kidney Failure, Chronic Blood Transfusion, Autologous Cancer
Pharmacotherapeutic Group: Antianemic preparations

Therapeutic Indication

· Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients;

· treatment of symptomatic anaemia in adult patients with non-myeloid malignancies receiving chemotherapy;

· increasing the yield of autologous blood from patients in a pre-donation programme. Its use in this indication must be balanced against the reported increased risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (Hb 10 - 13 g/dl [6.21 - 8.07 mmol/l], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).

What is NeoRecormon?

NeoRecormon is a medicine that stimulates red-blood-cell growth. It is available as a powder and solvent in a multidose vial, to be made up into a solution for injection. It is also available as a pre-filled syringe. NeoRecormon is available in various strengths from 500 to 50,000 international units (IU). It contains the active substance epoetin beta.

What is NeoRecormon used for?

NeoRecormon is used in the following situations:

· to treat anaemia (low red blood cell counts) that is causing symptoms in adults and children with chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly);

· to prevent anaemia in premature babies;

· to treat anaemia that is causing symptoms in adults who are receiving chemotherapy for ‘non-myeloid’ cancer (cancer that does not affect the bone marrow);

· to increase the amount of blood that can be taken from adult patients with moderate anaemia who are going to have an operation and need to have a supply of their own blood before surgery (autologous blood transfusion).This is only done when blood storage procedures are not available or are insufficient because the surgery requires a large volume of blood.

How is NeoRecormon used?

Treatment with NeoRecormon should be initiated by a doctor who has experience in the care of patients with the types of anaemia that NeoRecormon is used to treat and prevent. The medicine can only be obtained with a prescription.

For patients with chronic renal failure, NeoRecormon can be injected into a vein or under the skin, but it must be injected under the skin in premature babies and patients receiving chemotherapy, and into a vein in patients who are going to have their blood extracted for their surgery. The dose, the frequency of injection, and how long it is used for depend on why NeoRecormon is used, and are adjusted according to the patient’s response to treatment. For more details, see the package leaflet.

How does NeoRecormon work?

The active substance in NeoRecormon, epoetin beta, is a copy of a human hormone called erythropoietin. Erythropoietin is produced by the kidneys and stimulates the production of red blood cells from the bone marrow. In patients receiving chemotherapy or with chronic renal failure, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally. The epoetin beta in NeoRecormon works in the body in the same way as the natural hormone to stimulate red blood cell production.

How has NeoRecormon been studied?

The effectiveness of NeoRecormon to treat or prevent anaemia has been studied in many studies including anaemia in chronic renal failure (1,663 patients, including some comparative studies against placebo (a dummy treatment)), autologous blood transfusion (419 patients, comparison with placebo), anaemia in premature babies (177 babies, comparison with no treatment), and in cancer patients (1,204 patients with different types of cancer, comparison with placebo). The main measures of effectiveness in most of the studies were whether NeoRecormon increased haemoglobin levels or whether it reduced the need for blood transfusions.

What benefit has NeoRecormon shown during the studies?

NeoRecormon was more effective than placebo at increasing haemoglobin levels in patients with various types of anaemia, including those with chronic renal failure. It also increased the amount of blood that could be taken from patients before surgery for autologous blood transfusion and reduced the need for transfusion in premature babies and in cancer patients receiving chemotherapy.

What is the risk associated with NeoRecormon?

The types of side effects seen with NeoRecormon depend on the cause of the patient’s anaemia. The most common side effects (seen in between 1 and 10 patients in 100) are hypertension (high blood pressure), headache and thromboembolic events (formation of blood clots in the blood vessels). For the full list of all side effects reported with NeoRecormon, see the package leaflet.

NeoRecormon must not be used in patients who have poorly controlled high blood pressure. In patients who are to undergo autologous blood transfusion, NeoRecormon must not be used if they have had a heart attack or stroke within the last month, if they have angina pectoris (a severe type of chest pain), or if they are at risk of deep venous thrombosis (DVT, formation of blood clots in the deep veins of the body, usually in the leg). The multidose formulation of NeoRecormon contains benzyl alcohol and must not be given to children below three years of age. For the full list of restrictions, see the package leaflet.

Why has NeoRecormon been approved?

The CHMP decided that NeoRecormon’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of NeoRecormon?

A risk management plan has been developed to ensure that NeoRecormon is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for NeoRecormon, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about NeoRecormon

The European Commission granted a marketing authorisation valid throughout the European Union for NeoRecormon on 17 July 1997.

For more information about treatment with NeoRecormon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.